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FDA 510(k) Application Details - K213670
Device Classification Name
Tubes, Vacuum Sample, With Anticoagulant
More FDA Info for this Device
510(K) Number
K213670
Device Name
Tubes, Vacuum Sample, With Anticoagulant
Applicant
Becton Dickinson and Company
1 Becton Drive
Franklin Lakes, NJ 07417 US
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Contact
Katherine Kenner Lemus
Other 510(k) Applications for this Contact
Regulation Number
862.1675
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Classification Product Code
GIM
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More FDA Info for this Product Code
Date Received
11/22/2021
Decision Date
08/25/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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